Good news flowed in at
Gilead Sciences Inc.
) from Europe regarding its drug Viread. The European Commission
(EC) cleared the drug for a couple of additional indications.
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Following the clearance by the EC, Viread (as a combination
therapy) will be marketed in the EU for treating HIV infected
children aged between 2 and 18 years. The EC also approved Viread
for treating adolescents, aged above 12 but less than 18 years,
infected with chronic hepatitis B virus.
The approval by the EC will allow Gilead to market a new oral
granule version of Viread for treating HIV infected children aged
between 2 and 6 years in the EU. The oral granule formulation of
the drug will also be available in the EU for treating HIV
infected children above 6 years of age for whom a solid dosage
version is inappropriate.
Moreover, the EC also cleared Viread tablets to be marketed in
the EU at three new lower dosages (123 mg, 163 mg and 204 mg) for
treating HIV infected children aged between 6 and 12 years.
We note that Viread is already available in the EU as a
combination therapy for treating HIV infected adults and also for
chronic HBV. Approval for additional indications in the EU would
further boost Viread's sales potential. Viread competes primarily
We remind investors that in January 2012, the US Food and Drug
Administration (FDA) cleared Viread as a combination therapy in
children aged between 2 and 12 years for treating HIV. The US
agency cleared Viread in doses of 150 mg, 200 mg and 250 mg for
children in the age group of 6-12 years. Additionally, the FDA
also cleared an oral powder version of Viread for children aged
between 2 and 5 years.
We currently have a Neutral recommendation on Gilead. Gilead
carries a Zacks #3 Rank (Hold rating) in the short run.